TOPIRAMATE CADILA 100 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the patient

if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

What is in this leaflet

• 1. What Topiramate Tablets are and what they are used for

• 2. What you need to know before you take Topiramate Tablets

• 3. How to take Topiramate Tablets

• 4. Possible side effects

• 5. How to store Topiramate Tablets

• 6. Contents of the pack and other information

1. WHAT TOPIRAMATE TABLETS ARE AND WHAT THEY ARE USED FOR

Topiramate Tablets belong to a group of medicines called “antiepileptic medicines”. They can be used:

• alone to treat seizures in adults and children over age 6
• with other medicines to treat seizures in adults and children over age 2
• to prevent migraine headaches in adults

2. what you need to know before you take topiramate tablets

Do not take Topiramate Tablets:

• if you are allergic (hypersensitive) to topiramate, or any of the other ingredients in Topiramate Tablets (listed in section 6).
• for migraine prevention: if you are pregnant or if you are a woman of childbearing potential unless you are using effective contraception ( see section Pregnancy and breast-feeding for further information). You should talk to your doctor about the best kind of contraception to use while you are taking Topiramate Tablets.

If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Topiramate Tablets if you:

• have kidney problems, especially kidney stones or are getting kidney dialysis
• have a history of blood and body fluid abnormality (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have a growth problem
• are on a high fat diet (ketogenic diet)
• are taking Topiramate Tablets to treat epilepsy and you are pregnant or a woman of childbearing potential (see section ‘pregnancy and breast-feeding’ for further information)

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Topiramate Tablets.

It is important that you do not stop taking this medicine without first consulting your doctor.

You should also talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topiramate Tablets.

You may lose weight if you use Topiramate Tablets so your weight should be checked regularly when using this medicine. If you are losing too much weight or a child using this medicine is not gaining enough weight, you should consult your doctor.

A small number of people being treated with anti-epileptic medicines such as Topiramate Tablets have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Topiramate Tablets may in rare cases cause high levels of ammonia in the blood (seen in blood tests) which can lead to a change in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this may be a severe condition, tell your doctor immediately if the following symptoms occur (see also section 4 ‘Possible side effects’):

• difficulty thinking, remembering information, or solving problems
• being less alert or aware
• feeling very sleepy with low energy

At higher doses of Topiramate Tablets, the risk of developing these symptoms may increase.

Other medicines and Topiramate Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Topiramate Tablets and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or Topiramate Tablets will have to be adjusted.

Especially tell your doctor or pharmacist if you are taking:

• other medicines that impair or decrease your thinking, concentration or muscle coordination (e.g. central nervous system depressant medicines such as muscle relaxants and sedatives)
• birth control pills. Topiramate Tablets may make your birth control pills less effective. You should talk to your doctor about the best kind of contraception to use while you are taking Topiramate Tablets.

Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and Topiramate Tablets.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.

Other medicines you should discuss with your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothi­azide, metformin, pioglitazone, glyburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine St. John's wort (Hypericum perforatum ) (a herbal preparation used to treat depression), warfarin used to thin the blood.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before you start a new medicine.

Topiramate Tablets with food and drink

Topiramate Tablets can be taken with or without food. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate Tablets. You should avoid drinking alcohol while taking Topiramate Tablets.

Pregnancy and breast-feeding

Migraine prevention:

Topiramate Tablets can harm an unborn baby. You must not use Topiramate Tablets if you are pregnant. You must not use Topiramate Tablets for migraine prevention if you are a woman of childbearing potential unless you are using effective contraception. Talk to your doctor about the best kind of contraception and whether Topiramate Tablets are suitable for you. Before the start of treatment with Topiramate Tablets a pregnancy test should be performed.

Treatment of epilepsy:

If you are a woman of childbearing potential you should talk to your doctor about other possible treatments instead of Topiramate Tablets. If the decision is made to use Topiramate Tablets, you should use effective contraception. Talk to your doctor about the best kind of contraception to use while you are taking Topiramate Tablets. Before the start of treatment with Topiramate Tablets a pregnancy test should be performed.

If you are planning to become pregnant you should discuss your epilepsy treatment with your doctor as early as possible before you become pregnant.

If you are pregnant, or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the epilepsy medicine you are taking might pose to your unborn baby. You and your doctor should decide if you will continue to take Topiramate Tablets while you are pregnant.

You should not stop your treatment without discussing this with your doctor. Suddenly stopping may lead to breakthrough seizures which may harm you and your unborn baby. It is important that your epilepsy remains well controlled.

As with other anti-epileptic medicines, there is a risk of harm to the unborn child if Topiramate Tablets are used during pregnancy.

• If you take Topiramate Tablets during pregnancy, your baby has a higher risk for physical birth abnormalities, particularly, cleft lip (split in the top lip) and cleft palate (split in the roof of the mouth). Newborn boys may also have a malformation of the penis (hypospadia). These defects can develop early in pregnancy, even before you know you are pregnant.
• Studies with women treated with topiramate for epilepsy have shown that on average 4–5 babies in every 100 will have serious physical birth abnormalities. This compares to 2 to 3 babies in every 100 born to women who do not have epilepsy.
• The higher the dose of Topiramate Tablets, the higher the risk of physical birth abnormalities but all doses carry a risk. It is important that where possible you are prescribed the lowest dose to control your epilepsy.
• Taking more than one epilepsy medicine at the same time may also increase the risk of physical birth abnormalities. This means that where possible, your doctor should consider using one epilepsy medicine to control your epilepsy.
• If you take Topiramate Tablets during pregnancy, your baby may be smaller than expected at birth. Talk to your doctor if you have questions about this risk during pregnancy.
• There may be other medicines to treat your condition that have a lower risk of birth defects.

Breast-feeding

The active substance in Topiramate Tablets (topiramate) passes into human milk. Effects have been seen in breastfed babies of treated mothers, including diarrhoea, feeling sleepy, feeling irritable, and poor weight gain. Therefore, your doctor will discuss with you whether you abstain from breast-feeding or whether to abstain from treatment with Topiramate Tablets. Your doctor will take into account the importance of the medicine to the mother and the risk for the baby.

Mothers who breast-feed while taking Topiramate Tablets must tell their doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

Dizziness, tiredness and vision problems may occur during treatment with Topiramate Tablets. Do not drive or use any tools or machines without talking to your doctor first.

Topiramate Tablets contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take topiramate tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• Your doctor will usually start you on a low dose of topiramate and slowly increase your dose until the best dose is found for you.
• Topiramate Tablets are to be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• Topiramate Tablets can be taken before, during, or after a meal. Drink plenty of fluids during the day to prevent kidney stones while taking topiramate.

If you take more Topiramate Tablets than you should

• See a doctor right away. Take the medicine pack with you.
• You may feel sleepy, tired, or less alert; lack coordination; have difficulty speaking or concentrating; have double or blurred vision; feel dizzy due to low blood pressure; feel depressed or agitated; or have abdominal pain, or seizures (fits).

Overdose can happen if you are taking other medicines together with Topiramate Tablets.

If you forget to take Topiramate Tablets

• If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Topiramate Tablets

Do not stop taking this medicine unless told to do so by your doctor. Your symptoms may return. If your doctor decides to stop this medication, your dose may be decreased gradually over a few days.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor, or seek medical attention immediately if you have the following side effects:

Very common (may affect more than 1 in 10 people):

• depression (new or worse)

Common (may affect up to 1 in 10 people):

• Seizures (fits)
• Anxiety, irritability, changes in mood, confusion, disorientation
• Problems with concentration, slowness of thinking, loss of memory, problems with memory (new onset, sudden change or increased severity)
• Kidney stone, frequent or painful urination

Uncommon (may affect up to 1 in 100 people):

• Increased acid level in the blood (may cause troubled breathing including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and fast or uneven heart beats)
• Decreased or loss of sweating (particularly in young children who are exposed to high temperatures)
• Having thoughts of serious self-harm, trying to cause serious self-harm
• Loss of part of the field of vision

Rare (may affect up to 1 in 1,000 people):

• Stevens Johnson syndrome, a potentially life-threatening condition that may present with sores in multiple mucosal sites (such as the mouth, nose, and eyes), a skin rash, and blistering.
• Glaucoma – blockage of fluid in eye causing increased pressure in the eye, pain, or decreased vision
• Difficulty thinking, remembering information, or solving problems, being less alert or aware, feeling very sleepy with low energy – these symptoms may be a sign of a high level of ammonia in the blood (hyperammonemia), which can lead to a change in brain function (hyperammonemic encephalopathy).

Not known: frequency cannot be estimated from the available data:

• Toxic epidermal necrosis, a life-threatening condition related to, yet more severe than, Stevens-Johnson syndrome, characterized by widespread blistering and sloughing of the outer layers of the skin (see rare side effects).
• Inflammation of the eye (uveitis) with symptoms such as eye redness, pain, sensitivity to light, runny eyes, seeing small dots or getting blurred vision

Other side effects include the following, if they get serious, please tell your doctor or pharmacist:

Very common (may affect more than 1 in 10 people)

• Stuffy, runny nose or sore throat
• Tingling, pain and/or numbness of various body parts
• Sleepiness, tiredness
• Dizziness
• Nausea, diarrhoea
• Weight loss

Common (may affect up to 1 in 10 people)

• Anaemia (low blood count)
• Allergic reaction (such as skin rash, redness, itching, facial swelling, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behaviour
• Difficulty falling or staying asleep
• Problems with speech or speech disorder, slurred speech
• Clumsiness or lack of coordination, feeling of unsteadiness when walking
• Decreased ability to complete routine tasks
• Decreased, loss of, or no sense of taste
• Involuntary trembling or shaking; rapid, uncontrollable movements of the eyes
• Visual disturbance, such as double vision, blurred vision, decreased vision, difficulty

focusing

• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Shortness of breath
• Cough
• Nose bleeds
• Fever, not feeling well, weakness
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or

intestinal infection

• Dry mouth
• Hair loss
• Itching
• Joint pain or swelling, muscle spasms or twitching, muscle aches or weakness, chest

pain

• Weight gain

Uncommon (may affect up to 1 in 100 people)

• Decrease in platelets (blood cells that help stop bleeding), decrease in white blood cells that help to protect you against infection, decrease in potassium level in the blood
• Increase in liver enzymes, increase in eosinophils (a type of white blood cell) in the blood
• Swollen glands in the neck, armpit, or groin
• Increased appetite
• Elevated mood
• Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis)
• Showing and/or feeling no emotion, unusual suspiciousness, panic attack
• Problems with reading, speech disorder, problems with handwriting
• Restlessness, hyperactivity
• Slowed thinking, decreased wakefulness or alertness
• Reduced or slow body movements, involuntary abnormal or repetitive muscle movements
• Fainting
• Abnormal sense of touch; impaired sense of touch
• Impaired, distorted, or no sense of smell
• Unusual feeling or sensation that may precede a migraine or a certain type of seizure
• Dry eye, sensitivity of the eyes to light, eyelid twitching, watery eyes
• Decreased or loss of hearing, loss of hearing in one ear
• Slow or irregular heartbeat, feeling your heart beating in your chest
• Low blood pressure, low blood pressure upon standing (consequently, some people taking Topiramate Tablets may feel faint, dizzy, or may pass out when they stand up or sit up suddenly)
• Flushing, feeling warm
• Pancreatitis (inflammation of the pancreas)
• Excessive passing of gas or wind, heartburn, abdominal fullness or bloating
• Bleeding gums, increased saliva, drooling, breath odour
• Excessive intake of fluids, thirst
• Skin discolouration
• Muscle stiffness, pain in side
• Blood in urine, incontinence (lack of control) of urine, urgent desire to urinate, flank or kidney pain
• Difficulty getting or keeping an erection, sexual dysfunction
• Flu-like symptoms
• Cold fingers and toes
• Feeling drunk
• Learning disability

Rare (may affect up to 1 in 1,000 people)

• Abnormally elevated mood
• Loss of consciousness
• Blindness in one eye, temporary blindness, night blindness
• Lazy eye
• Swelling in and around the eyes
• Numbness, tingling and colour change (white, blue then red) in fingers and toes when exposed to the cold
• Inflammation of the liver, liver failure
• Abnormal skin odour
• Discomfort in your arms or legs
• Kidney disorder

Not known (frequency cannot be estimated from the available data)

• Maculopathy is a disease of the macula, the small spot in the retina where vision is keenest. You should call your doctor if you notice a change or decrease in your vision.

Children

The side effects in children are generally similar to those seen in adults, but the following side effects may be more common in children than adults:

• Problems with concentration
• Increased acid level in the blood
• Having thoughts of serious self-harm
• Tiredness
• Decreased or increased appetite
• Aggression, abnormal behaviour
• Difficulty falling or staying asleep
• Feeling of unsteadiness when walking
• Not feeling well
• Decrease in potassium level in the blood
• Showing and/or feeling no emotion
• Watery eyes
• Slow or irregular heartbeat

Other side effects that may occur in children are:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (vertigo)
• Vomiting
• Fever

Uncommon (may affect up to 1 in 100 people)

• Increase in eosinophils (a type of white blood cell) in the blood
• Hyperactivity
• Feeling warm
• Learning disability

5. how to store topiramate tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after (Exp.). The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Topiramate Tablets contain:

The active substance is topiramate.

Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate.

Tablet core:

The ingredients are lactose monohydrate, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.

Film-coating:

Topiramate 25 mg Tablets are coated with the ingredients of titanium dioxide, hypromellose, polysorbate 80 and indigo carmine aluminium lake (E132).

Topiramate 50 & 100 mg Tablets are coated with the ingredients of titanium dioxide, hypromellose, polysorbate 80, iron oxide yellow (E172) and iron oxide red (E172).

Topiramate 200 mg Tablets are coated with the ingredients of titanium dioxide, hypromellose, polysorbate 80 and iron oxide red (E172).

What Topiramate Tablets look like and the contents of the pack:

Topiramate 25 mg: white coloured, circular, biconvex film-coated tablets.

Topiramate 50 mg: light-orange coloured, circular, biconvex film-coated tablets.

Topiramate 100 mg: orange coloured, circular, biconvex film-coated tablets.

Topiramate 200 mg: pink coloured, biconvex, caplet-shaped film-coated tablets.

Topiramate Tablets are available in containers of 60, 100 & 200 film-coated tablets and blister packs of 28, 56, 60 & 84 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder :

Cadila Pharmaceuticals (Europe) Ltd, The Pavilion, 56 Rosslyn Crescent, Harrow, Middlesex

HA1 2SZ, UK

Manufacturer:

Ennogen Healthcare Limited, Unit G2-G4, Riverside Industrial Estate, Riverside Way,

Dartford, DA1 5BS, UK

Crescent Pharma Limited, Unit 3 and 4, Quidhampton Business Units, Polhampton Lane, Overton, Hampton, Basingstoke RG25 3ED, United Kingdom.

Somex Pharma, 641 High Road, IG3 8RA, UK.

This leaflet was last revised in September 2021.